title: The effects of a maintenance therapy with peg-interferon alpha-2a on liver fibrosis in HIV/HCV co-infected patients: a randomized controlled trial.
abstract: OBJECTIVE
  We hypothesized that, in Human Immunodeficiency Virus and Hepatitis C Virus (HIV/HCV) co-infected patients who did not respond to peg-interferon and ribavirin, a maintenance therapy with peg-interferon could induce fibrosis regression.
  
  
  METHODS
  This was a randomized study with two parallel groups. HIV/HCV co-infected patients received peg-interferon α-2a at 180 μg/week or remained on observation for 96 weeks. The primary endpoint was the percentage of patients who experienced a decrease of at least one point in their Metavir fibrosis score between initial and final liver biopsies. Secondary endpoints included plasma fibrosis markers at week 96, occurrence of HCV-related complications, and survival.
  
  
  RESULTS
  A total of 52 patients were randomized (peg-interferon: 25; control: 27) including 18 with cirrhosis. The median (interquartile range) age was 44 (40-46) years, and 69% were male. A total of 64% had ALT levels >1.5 normal values, and the CD4 cell count was 391 (296-537) cells/mm(3); 67% of patients had HIV RNA <200 copies/mL at entry. The main endpoint was assessed in 41 patients. Response rates were 3/20 (15%) and 4/21 (19%) in the peg-interferon and control groups, respectively (p = 0.99). There was no significant difference between peg-interferon and control groups on plasma fibrosis markers at the final visit. Severe liver-related complications were observed in 2 and 5 patients in peg-interferon and control groups, respectively. Three deaths were observed, all in the control group.
  
  
  CONCLUSIONS
  A maintenance therapy with peg-interferon α-2a over 96 weeks in HIV/HCV co-infected patients, who were non-responders to HCV treatment, did not change liver fibrosis. ClinicalTrials.gov Identifier: NCT00122616.
authors.affiliation: Department of Infectious Diseases, Rennes University Hospital, Rennes 1 University, Rennes, France. jean-marc.chapplain@chu-rennes.fr
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Chapplain
authors.forename: Eric
authors.initials: E
authors.lastname: Bellissant
authors.forename: Dominique
authors.initials: D
authors.lastname: Guyader
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Molina
authors.forename: Isabelle
authors.initials: I
authors.lastname: Poizot-Martin
authors.forename: Philippe
authors.initials: P
authors.lastname: Perré
authors.forename: Gilles
authors.initials: G
authors.lastname: Pialoux
authors.forename: Bruno
authors.initials: B
authors.lastname: Turlin
authors.forename: Catherine
authors.initials: C
authors.lastname: Mouchel
authors.forename: Alain
authors.initials: A
authors.lastname: Renault
authors.forename: Christian
authors.initials: C
authors.lastname: Michelet
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage*; D001706:Biopsy; D005260:Female; D015658:HIV Infections / Q000150:complications*; D019698:Hepatitis C, Chronic / Q000150:complications* / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage*; D008103:Liver Cirrhosis / Q000188:drug therapy* / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D011994:Recombinant Proteins / Q000008:administration & dosage; D012720:Severity of Illness Index; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; C100416:peginterferon alfa-2a
keywords: HIV/HCV co-infection; Liver fibrosis; Metavir fibrosis score; Peg-interferon; Randomized controlled trial